Stress Urinary Incontinence

8
Pipeline Programs
8
Companies
15
Clinical Trials
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
2
0
2
4
Early DiscoveryClinical DevelopmentMarket

On Market (1)

Approved therapies currently available

U
DULOXETINE HYDROCHLORIDEApproved
duloxetine
Unknown Company
oral2019

Competitive Landscape

8 companies ranked by most advanced pipeline stage

Boehringer Ingelheim
Boehringer IngelheimINGELHEIM, Germany
3 programs
2
1
duloxetine HClPhase 41 trial
DuloxetinePhase 31 trial
DuloxetinePhase 31 trial
Active Trials
NCT00190632Completed600Est. Apr 2006
NCT00190645Completed600Est. May 2006
NCT00190905Completed4,000Est. Jul 2005
J&
Johnson & JohnsonNEW BRUNSWICK, NJ
1 program
1
TVT-OPhase 41 trial
Active Trials
NCT01095159Completed124Est. Dec 2013
Astellas
AstellasChina - Shenyang
1 program
1
solifenacinPhase 41 trial
Active Trials
NCT01505439Completed311Est. Jun 2014
Pfizer
PfizerNEW YORK, NY
1 program
1
FesoterodinePhase 21 trial
Active Trials
NCT01042236Completed22Est. Jul 2010
Versameb
VersamebSwitzerland - Basel
1 program
1
VMB-100Phase 21 trial
Active Trials
NCT06247241WithdrawnEst. Apr 2029
C
ColoplastAustralia - Mulgrave
6 programs
Altis Single Incision SlingN/A1 trial
Altis Single Incision Sling SystemN/A1 trial
Altis® Single Incision Sling SystemN/A1 trial
Coloplast Virtue® Male SlingN/A1 trial
Virtue® Male Incontinence SlingN/A1 trial
+1 more programs
Active Trials
NCT02348112CompletedEst. Sep 2021
NCT02049840CompletedEst. Jul 2021
NCT01272284CompletedEst. Jan 2014
+3 more trials
Thea Pharma
Thea PharmaMA - Waltham
1 program
Dorsal genital nerve stimulationN/A1 trial
Active Trials
NCT05804552CompletedEst. Mar 2023
Verathon
VerathonBC - Burnaby
1 program
LyretteN/A1 trial
Active Trials
NCT01455779Unknown54Est. Jul 2015

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
Astellassolifenacin
Johnson & JohnsonTVT-O
Boehringer Ingelheimduloxetine HCl
Boehringer IngelheimDuloxetine
Boehringer IngelheimDuloxetine
VersamebVMB-100
PfizerFesoterodine
Thea PharmaDorsal genital nerve stimulation
ColoplastAltis Single Incision Sling
ColoplastAltis Single Incision Sling System
ColoplastVirtue® Male Sling
VerathonLyrette
ColoplastAltis® Single Incision Sling System
ColoplastColoplast Virtue® Male Sling
ColoplastVirtue® Male Incontinence Sling

Clinical Trials (15)

Total enrollment: 5,711 patients across 15 trials

NCT01505439Astellassolifenacin

A Study to Estimate the Efficacy and Safety of Solifenacin in Female With Stress Urinary Incontinence and Urgency Urinary Incontinence

Start: Jun 2011Est. completion: Jun 2014311 patients
Phase 4Completed
NCT01095159Johnson & JohnsonTVT-O

TVTO™ X TVTS ™ for Treatment of Stress Urinary Incontinence

Start: Feb 2009Est. completion: Dec 2013124 patients
Phase 4Completed
NCT00190905Boehringer Ingelheimduloxetine HCl

Safety and Effectiveness Study of Duloxetine HCl in Women of Different Backgrounds With Stress Urinary Incontinence Who May Also Have Other Various Medical Conditions.

Start: Feb 2004Est. completion: Jul 20054,000 patients
Phase 4Completed
NCT00190632Boehringer IngelheimDuloxetine

To Evaluate the Safety in Patients Taking Duloxetine for Stress Urinary Incontinence

Start: Mar 2001Est. completion: Apr 2006600 patients
Phase 3Completed
NCT00190645Boehringer IngelheimDuloxetine

To Evaluate the Safety of Duloxetine in Patients With Stress Urinary Incontinence

Start: Feb 2001Est. completion: May 2006600 patients
Phase 3Completed
NCT06247241VersamebVMB-100

A Phase 2a Study To Evaluate VMB-100 In Females With Stress Urinary Incontinence

Start: Sep 2025Est. completion: Apr 2029
Phase 2Withdrawn
NCT01042236PfizerFesoterodine

Evaluation Of The Ability Of Fesoterodine To Increase Urethral Pressure In Stress Urinary Incontinence Patients

Start: Jan 2009Est. completion: Jul 201022 patients
Phase 2Completed
NCT05804552Thea PharmaDorsal genital nerve stimulation

The Effect of Dorsal Genital Nerve Stimulation on Opening Urethral Pressure

Start: Mar 2023Est. completion: Mar 2023
N/ACompleted
NCT02348112ColoplastAltis Single Incision Sling

Altis® 522 Trial - Treatment of Female Stress Urinary Incontinence

Start: Jan 2015Est. completion: Sep 2021
N/ACompleted
NCT02049840ColoplastAltis Single Incision Sling System

The European Study of Altis Single Incision Sling System for Female Stress Urinary Incontinence

Start: Dec 2013Est. completion: Jul 2021
N/ACompleted
NCT01608789ColoplastVirtue® Male Sling

Virtue® European Study

Start: Aug 2012Est. completion: Jun 2018
N/ACompleted
NCT01455779VerathonLyrette

Lyrette: Renewing Continence Objective and Subjective Efficacy Study

Start: Sep 2011Est. completion: Jul 201554 patients
N/AUnknown
NCT01272284ColoplastAltis® Single Incision Sling System

The Altis® Single Incision Sling System for Female Stress Urinary Incontinence Study

Start: Dec 2010Est. completion: Jan 2014
N/ACompleted
NCT01170728ColoplastColoplast Virtue® Male Sling

Virtue® Male Sling Fixation Study

Start: Jul 2010Est. completion: Jun 2014
N/ATerminated
NCT00856778ColoplastVirtue® Male Incontinence Sling

Virtue® Male Incontinence Sling Study

Start: Jan 2009Est. completion: Jan 2011
N/ACompleted

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

2 late-stage (Phase 3) programs — potential near-term approvals
8 companies competing in this space